Validation of a questionnaire in Pancreatic Exocrine Insufficiency
Research type
Research Study
Full title
Psychometric validation of a Patient-Reported Outcome in Pancreatic Exocrine Insufficiency (PEI)
IRAS ID
170145
Contact name
Nicola Bonner
Contact email
Sponsor organisation
Abbott
Duration of Study in the UK
1 years, 1 months, 3 days
Research summary
Pancreatic Exocrine Insufficiency (PEI) commonly affects patients with Chronic Pancreatitis (CP) and Cystic Fibrosis (CF) who are unable to produce sufficient amounts of pancreatic enzymes to digest food. Patients with PEI often experience steatorrhoea, diarrhoea and abdominal pain symptoms.
The goal of this study is to validate a two-part patient-reported outcome (27 questions) developed to aid diagnosis and further understand the patient's experience of living with their PEI and to better manage the patient's disease. Section 1 assesses symptoms (18 questions), while section 2 assesses impacts of PEI (9 questions). To ensure that the questionnaire assesses all the relevant concepts to PEI patients, it will be psychometrically validated in the UK, France, Germany and Spain on three samples (n=325): patients with CF or CP and PEI (n=205), patients with a Irritable Bowel Syndrome (IBS) who do not have PEI (n=60), and healthy patients who do not have PEI, IBS or any gastrointestinal disorder (n=60). The purpose of including the three samples will allow us to assess the relevance of the questions to PEI and whether they can differentiate between patients with and without PEI.
PEI patients will be asked to complete both sections of the questionnaire on two occasions, while the other two samples will be asked to complete section 1 of the questionnaire once only. Of note, the PEI patients will be asked to complete both sections 1 and 2 of the questionnaire, while the IBS and healthy control patients will only be asked to complete section 1 of the questionnaire. This is because section 2 is designed to assess specific impacts of PEI. Patients will also be asked to complete the Gastrointestinal Quality of Life Index (36 questions). The purposes of two time points will allow the assessment of symptom change and severity over time among the PEI patients.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0357
Date of REC Opinion
21 May 2015
REC opinion
Further Information Favourable Opinion